U.S. FDA Drug Master File Requirements

Drug companies can submit a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information in support of a submission to FDA without disclosing the information to anyone other than FDA.

FDA requires all DMF submissions to be in electronic common technical document (eCTD) format beginning May 5, 2018.